On January 23, 2020 iOnctura B.V., a clinical stage biopharmaceutical company, developing a pipeline of next generation molecules targeting cancer and fibrosis, reported the closing of a EUR 15 million Series A financing (Press release, iOnctura, JAN 23, 2020, View Source [SID1234553458]). The financing was led by INKEF Capital and co-led by VI Partners with participation by new investor Schroder Adveq. iOnctura’s founding investor, M Ventures, also participated in the fundraise. iOnctura was founded in 2017 as a spin-out from Merck, with Merck and Cancer Research UK providing a best-in-class pipeline of molecules that harness both direct and immune-mediated anti-cancer activities in solid cancers and cancer fibrosis.

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iOnctura will use the proceeds of the Series A to move its lead molecule IOA-244, a highly selective PI3Kδ-inhibitor, into a Phase I trial in solid tumours and its second program, IOA-289, an ATX-inhibitor, through IND enabling studies. The superior properties of IOA-244 are expected to enable iOnctura to be the first company to clinically demonstrate that highly selective PI3Kδ inhibition not only drives an immune-mediated response but also a direct anti-tumoural effect in a stratified patient population across multiple solid tumour indications.

The board of directors of iOnctura BV welcomes Fiona MacLaughlin, of INKEF Capital and Diego Braguglia of VI Partners.

Catherine Pickering, Chief Executive Officer of iOnctura, commented: "iOnctura has made significant progress with its two lead molecules which are being developed as next generation dual immune and tumour targeting therapies. We are very excited to move our first molecule into human clinical testing and accelerate our second molecule towards clinical trials.

We welcome new investors INKEF Capital, VI Partners and Schroder Adveq to iOnctura and with the continued support from our founding investor M Ventures, we look forward to taking iOnctura into the next stage of development."

Fiona MacLaughlin, Director of INKEF Capital, said: "INKEF’s strategy is to support talented management teams developing novel treatments that address high unmet medical needs via novel scientific insights and understanding. The highly experienced executive management team led by Catherine at iOnctura have a solid track record in drug development and commercialisation. Together with the scientific contribution of its world class scientific advisory board and its research partner Cancer Research UK, iOnctura has consolidated a scientific understanding we consider to be a true and valuable differentiator."

Hakan Goker, Chairman of iOnctura board and Executive Investment Director, M Ventures, added: "We helped found iOnctura to deliver clinical validation of emerging new biology around direct and immune mediated effects of key targets in cancer and fibrosis. The differentiated and targeted clinical approach iOnctura is using offers significant potential to treat patients with life-threatening diseases. We are excited to provide continued support to iOnctura as it advances its pipeline into the clinic."

iOnctura’s most advanced program, IOA-244, is a clinical phase, next generation PI3Kδ inhibitor with a unique chemical structure, exquisite selectivity, excellent drug-like properties and an expected best-inclass safety profile. Its second program, IOA-289, is a novel autotaxin (ATX) inhibitor with superior potency compared to clinical-stage ATX inhibitors. IOA-289 is being developed as a first-in-class therapy for solid tumour indications that over express ATX and are burdened with cancer-associated fibrosis. IOA-289 has demonstrated anti-tumour and anti-fibrotic efficacy in preclinical models and is in advanced in vivo safety studies.

On January 23, 2020 UT Southwestern Simmons Cancer Center reported have discovered a two-drug combo that halts the growth of cancer cells that carry HER2 mutations (Press release, The University of Texas Southwestern Medical Center, JAN 23, 2020, View Source [SID1234553457]).

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The findings, published today in the journal Cancer Cell, were prompted by the observation that, after an initial response, patients with cancers harboring HER2 mutations eventually develop resistance to a promising new cancer drug currently in clinical trials.

The scientists found that another drug, already on the market, counters that resistance and blocks the cancer, thereby providing the basis for a novel drug combination against cancers with mutations in the HER2 gene.

Dhivya Sudhan, Ph.D., a postdoctoral research fellow in the Harold C. Simmons Comprehensive Cancer Center, and collaborators evaluated data from a molecularly guided trial where patients with tumors with HER2 mutations were treated with the HER2 inhibitor neratinib. In this study, patients’ cancers were sequenced as the disease progressed during treatment. Based on this analysis, Sudhan discovered in the laboratory that an effective way to offset eventual resistance to neratinib is with everolimus, a TORC1 inhibitor commonly used to treat other types of breast cancer.

"This finding may give clinicians an effective response to neratinib resistance. That could make a real difference for patients with breast, ovarian, lung, and other cancers harboring HER2 mutations," says Carlos L. Arteaga, M.D., Director of the Simmons Cancer Center at UT Southwestern and corresponding author of the study.

HER2 mutations have long been identified as a key driver in breast and other cancers. The authors of this study zeroed in on a signaling network driven by TORC1, which they showed is the pathway through which HER2-mutant cancers become neratinib-resistant.

"We consistently noted activation of TORC1 signaling as a mechanism of resistance to neratinib across different types of HER2-mutant cancers. Different cancer types used different strategies to escape neratinib, but they all converged on TORC1 signaling," Sudhan says.

In addition to studying tumor sequencing data from HER2-mutant cancer patients across the country who are in clinical trials for neratinib, Sudhan also studied neratinib-resistant cells and tumors that continue to live and grow in the laboratory.

The sequencing of the patients’ cancer before and during the clinical trial showed that some patients already had a mutation that could activate the TORC1 pathway. Others would develop it eventually, but they could benefit from everolimus which is currently used as a TORC1 inhibitor to address the other roles TORC1 plays in cancer. Everolimus would allow the patient to continue benefiting from neratinib’s inhibition of HER2.

Sudhan says the combination of neratinib and everolimus worked in cell lines, organoids established from patient-derived tumors, and in mice harboring HER2 mutant tumors. The next step will be testing this two-drug combo in humans.

Other authors were Angel Guerrero-Zotano, M.D., of the Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee; Helen Won, M.S., of Memorial Sloan Kettering Cancer Center, New York; Paula González Ericsson, M.D., of the Comprehensive Cancer Center, University of New Mexico, Albuquerque, New Mexico; Alberto Servetto, M.D., of the Simmons Cancer Center at UT Southwestern; Mariela H. Rosario, M.D., of the Simmons Cancer Center at UT Southwestern; Dan Ye, M.D., of the Simmons Cancer Center at UT Southwestern; Kyung-min Lee, Ph.D., of the Simmons Cancer Center at UT Southwestern; Luigi Formisano, M.D., Ph.D., of the Department of Medicine, Vanderbilt University Medical Center; Yan Guo, Ph.D., of the Comprehensive Cancer Center, University of New Mexico; Qi Liu, Ph.D., of the Center for Quantitative Sciences, Vanderbilt University Medical Center; Lisa N. Kinch, Ph.D., of UT Southwestern; Monica R. Brewer, Ph.D., of the Department of Medicine, Vanderbilt University Medical Center; Teresa Dugger of the Department of Medicine, Vanderbilt University Medical Center; James Koch, M.S., of the Department of Medicine, Vanderbilt University Medical Center; Michael J. Wick, Ph.D., of the START Center for Cancer Care, San Antonio; Richard E. Cutler Jr., Ph.D., of Puma Biotechnology Inc., Los Angeles; Alshad S. Lalani of Puma Biotechnology Inc.; Richard Bryce of Puma Biotechnology Inc.; Alan Auerbach, M.S., of Puma Biotechnology Inc.; and Ariella B. Hanker, Ph.D., of UT Southwestern.

Cutler, Lalani, and Auerbach are employees of and hold ownership interest (including patents) in Puma Biotechnology Inc. Guerrero-Zotano has received research and travel grants from Pfizer. Hanker receives research grant support from Takeda. Arteaga is a consultant to Puma Biotechnology. He receives or has received research grants from Puma Biotechnology, Pfizer, Lilly, Bayer, Takeda, and Radius; holds stock options in Provista and Y-TRAP; serves or has served in an advisory role to Novartis, Merck, Lilly, Symphogen, Daiichi Sankyo, Radius, Taiho Oncology, H3 Biomedicine, OrigiMed, Puma Biotechnology, and Sanofi; and reports Scientific Advisory Board remuneration from the Komen Foundation.

The study was funded by the Simmons Cancer Center (P30 CA142543, 440), the Cancer Prevention & Research Institute of Texas (RR170061), the National Cancer Institute Breast SPORE (P50 CA098131), the Vanderbilt-Ingram Cancer Center (P30 CA68485), Susan G. Komen Breast Cancer Foundation (SAC100013), the Breast Cancer Research Foundation (R01CA224899), and the Susan G. Komen Postdoctoral Fellowship (PDF17487926). The authors acknowledge the assistance of the UT Southwestern Tissue Resource supported by the National Cancer Institute (5P30CA142543).

On January 23, 2020 Cancer Research Center of Toulouse reported that Immunotherapies are imposing themselves as a revolution in cancer treatment, giving hope to many previously incurable patients (Press release, Cancer Research Center of Toulouse, JAN 23, 2020, View Source [SID1234553456]). They aim to restore the natural defences mounted by the body against cancerous cells, such as lymphocytes, which are often disarmed by the tumour. Despite the promising potential, around 30% of patients do not benefit at all from immunotherapy. Better characterising the inter-cellular interactions in the tumour microenvironment will be key to propose new kinds of immunotherapy.

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LungPredict involves performing a deep molecular characterisation of lung cancer patients at diagnosis, to offer them personalised therapeutic approaches. The pilot phase (2019) consisted in developing logistic, experimental and bioinformatic protocols, assessing the feasibility of the full project.

The plan is to produce transcriptomics, targeted sequencing and high-content imaging on tumour samples for a few hundred patients. Blood is also being collected for future analyses and all data is linked to patients’ clinical records.

As part of this alliance between the company, researchers and clinicians, more similar projects will be launched in the future to exploit an integrative approach to achieve better personalized treatments for other cancers as well.

On January 23, 2020 Onconova Therapeutics, Inc. (NASDAQ: ONTX), a Phase 3-stage biopharmaceutical company discovering and developing novel products to treat cancer, with an initial focus on myelodysplastic syndromes (MDS), reported that it has regained the rights to rigosertib in Greater China (Press release, Onconova, JAN 23, 2020, View Source [SID1234553440]). Onconova regained the rights from HanX Biopharmaceuticals (HanX) as a result of the termination of the Onconova-HanX License Agreement pursuant to its terms due to HanX failing to make required payments under the agreement. In exchange for transition assistance and upon further regulatory, development and commercial progress in Greater China, HanX may be eligible to receive from Onconova incentive milestones and royalty payments. The Greater China territory, including mainland China, Hong Kong, Macau and Taiwan, represents one of the key world pharmaceutical markets.

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"We are pleased to regain rigosertib rights for Greater China, and we are encouraged by the opportunity to partner rigosertib in select territories including Greater China as we approach the potential corporate catalyst of topline data for the registrational INSPIRE Trial in 1H 2020," said Dr. Steven Fruchtman, President and Chief Executive Officer of Onconova. "We thank HanX for their collaborative efforts to advance rigosertib in this key market including the filing of the rigosertib IND in China." Dr. Fruchtman continued, "In 2019, we added partners Knight Therapeutics for Canada, Specialised Therapeutics for Australia & New Zealand, and Inceptua Medicines Access in select countries for pre-approval access to our roster of global corporate partners, joining Pint Pharma for Latin America and SymBio Pharmaceuticals for Japan & Korea. The United States, Europe, and Greater China represent the major pharmaceutical markets Onconova directly controls heading into INSPIRE data read out."

On January 23, 2020 Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) reported the pricing of the underwritten public offering previously announced by Chi-Med on January 21, 2020 (Press release, Hutchison China MediTech, JAN 23, 2020, https://www.chi-med.com/chi-med-announces-pricing-of-us110-million-public-offering-of-adss/ [SID1234553438]). Chi-Med will issue and sell 4,400,000 American Depositary Shares ("ADSs"), each representing five ordinary shares, par value US$0.10 each, of Chi-Med at a price of US$25.00 per ADS on the Nasdaq Global Select Market ("Offering"). The gross proceeds to Chi-Med from the Offering, before deducting underwriting discounts and commissions and other offering expenses, are expected to be approximately US$110 million. In addition, Chi-Med has granted the underwriters a 30-day option to purchase up to an additional 660,000 ADSs at the public offering price, less underwriting discounts and commissions. The Offering is expected to close on January 27, 2020, subject to customary closing conditions.

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Chi-Med will receive all of the net proceeds from the sale of ADSs in the Offering, which it intends to use primarily to fund its ongoing research and clinical development efforts and expand its commercialization capabilities.

BofA Securities, Inc., Goldman Sachs (Asia) L.L.C. and Morgan Stanley & Co. LLC (in alphabetical order) are acting as joint global coordinators and joint bookrunners for the Offering. Deutsche Bank Securities Inc. and HSBC Securities (USA) Inc. are acting as joint bookrunners, and Canaccord Genuity LLC, CLSA Limited and Panmure Gordon (UK) Limited are acting as co-managers.